Epidemiology of Hepatitis B, C and D and HIV Along the Maroni River Bordering French Guiana and Suriname (MaHeVi)

NCT05002907 | Completed DMC

• 1 other identifier: MaHeVi
• Study Type: observational
• Target: 2,289
• Locations: 2 countries
• Sites: 2

Brief Summary

MaHeVi is a multicenter, cross-sectional, population-based study which will include 2500 adults in the health care centers / missions located on the 2 sides of the Maroni River. All major inhabitants of the river border between French Guiana and Suriname may participate, after an extensive communication campaign.The main objective is to estimate the prevalence and status of infection with hepatitis B (HBV), hepatitis C (HCV), D (VHD) and HIV in the general adult population of the Maroni River, border between French Guiana and Suriname. After signing the informed consent and pre-test counseling, capillary blood will be collected on blotting paper. Participants will be interviewed on infection risk factors. Positivity for HBsAg, total anti-HBcAb, anti-HCV Ab, total anti-HDV Ab(for HBsAg positive) and HIV p24 Ag or anti-HIV Ab (confirmed by molecular biology for hepatitis and Western Blot for HIV) will inform respectively on the HBV, HCV, HDV and HIV infection status.

Conditions

Hepatitis B; Hepatitis C; Hepatitis D; HIV Infections; Prevalence; Epidemiology

Keywords

Epidemiology; Prevalence; Hepatitis B; Hepatitis C; Hepatitis D; HIV Infections; Phylogenetic; Molecular Biology

Outcome Measures

Primary Outcomes (5)

• Current active HBV infection

  Current active HBV infection determined by HBs Ag positivity

  Through study completion, an average of 1 year

• HBV infection carrier status

  Acute hepatitis B, chronic active hepatitis B, possible inactive chronic hepatitis B and resolved hepatitis B, determined by HBs Ag and total anti-HBcAb and if HBs Ag is positive by Anti-HBcIgM, HBV DNA and HBe Ag

  Through study completion, an average of 1 year

• HCV infection

  Anti-HCV Ab positivity confirmed by detection of HCV RNA

  Through study completion, an average of 1 year

• HDV infection

  Positivity for anti-HDV total Ab (on HBsAg positive samples only) and confirmation by detection of HDV RN

  Through study completion, an average of 1 year

• HIV infection

  Positive HIV p24 antigen and/or HIV antibodies (fourth-generation combined EIA), confirmed by HIV Ab positivity using Western-blot

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Questionnaire

  At Enrollment visit

• HBV, HCV and HDV genotyping and phylogenetics

  Through study completion, an average of 1 year

Study Arms (1)

General adult population living along the Maroni River in French Guiana and Suriname

General adult population living along the Maroni River in French Guiana and Suriname, upstream from Apatou. All adults (men and women) 18 years or older of both sexes will be able to participate in the study, in French Guiana and Suriname. Participation will be based on volunteering and signing informed consent. The acceptability and diversity of recruitment will be improved by seeking community support through community leaders and local associations and through appropriate communication (radio spots, posters in health centers and public establishments) before the survey .

Other: Questionnaire; Other: Biocollection; Other: Delivery of results; Other: Results and advices on transmission prevention methods; Other: Confirmation of results on a blood test (In the event of a positive result); Other: Information for care; Other: Monitoring and treatment

Interventions

Questionnaire OTHER

After signing the informed consent sheet, a standardized face-to-face questionnaire will be conducted by the doctor, nurse or coordinator to collect socio-demographic data, lifestyle data, sex life and other potential risk factors and knowledge about viral hepatitis.

General adult population living along the Maroni River in French Guiana and Suriname

Biocollection OTHER

After answering the questionnaire, the nurse or the doctor will take a sample of capillary blood from the fingertip on the side of the distal phalanx of a middle or ring finger. The puncture site will be prepared by warming and massage to optimize blood flow and disinfected with a disposable 70% alcohol wipe. After drying, the puncture will be performed using a single use safety lancet. A total of 7 capillary blood spotswill be collected and deposited on the filter paper (each spot is about 50µL of capillary blood), 5 for the study and 2 for the biological collection.

General adult population living along the Maroni River in French Guiana and Suriname

Delivery of results OTHER

After receiving the individual biological analysis results, in coded form (results only identified by the anonymity number), at the investigation center and lifting the anonymity by the coordinator of the study in each study center (in Cayenne or Paramaribo depending the country where the inclusion took place) with the help of the correspondance list, the participants' results will be delivered to the referral doctor of each health centre and the infectious disease specialist responsible for each area of inclusion. All positive participants will be contacted if they do not spontaneously come to retrieve their results (within approximately 1 month after result's availability), and invited to come to the health centre to retrieve their results individually and be oriented towards the heathcare circuit.

General adult population living along the Maroni River in French Guiana and Suriname

Results and advices on transmission prevention methods OTHER

The results will be revealed by the health centre's doctor/infectiologist, individually and confidentially, with an explanation of the results and advices on transmission prevention methods.Non-immunized patients against HBV will be offered a status determination (Anti-HBs Ab quantification on whole blood sample) and if necessary a catch-up vaccination according to the national immunization schedule.

General adult population living along the Maroni River in French Guiana and Suriname

Confirmation of results on a blood test (In the event of a positive result) OTHER

In case of a positive result, the doctor will explain the need to confirm these results on a blood test, prescribe the initial assessment and take an appointment with the infectious disease specialist. He will guide the patient towards accompaniment for the opening of medical coverage rights if necessary and support by an association if desired.

General adult population living along the Maroni River in French Guiana and Suriname

Information for care OTHER

A document with all contact information for a comprehensive and specialized care (professionals and associations for access to medical coverage and support, associations proposing support, general practitioners and specialists) will be given to positive participants. Patient monitoring and treatment will be carried out according to the national guidelines in each country.

General adult population living along the Maroni River in French Guiana and Suriname

Monitoring and treatment OTHER

Consequently, all positive participants will be able to be monitored and treated by a specialist of the disease. They will give post-test counselling and will conduct patient follow-up and treatment according to the usual standards of care of each country.

General adult population living along the Maroni River in French Guiana and Suriname

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General adult population living along the Maroni River in French Guiana and Suriname, upstream from Apatou. All adults (men and women) 18 years or older of both sexes will be able to participate in the study, in French Guiana and Suriname. Participation will be based on volunteering and signing informed consent. The acceptability and diversity of recruitment will be improved by seeking community support through community leaders and local associations and through appropriate communication (radio spots, posters in health centers and public establishments) before the survey.

You may qualify if:

• Age ≥ 18 years
• Signed informed consent

You may not qualify if:

• Consent withdrawal

Sponsors & Collaborators

• Centre Hospitalier de Cayenne: lead
• Foundation for Scientific Research Suriname (SWOS) Paramaribo, Suriname: collaborator

Study Sites (2)

General Hospital of Cayenne

Cayenne, 97306, French Guiana

Location

Foundation for Scientific Research Suriname (SWOS)

Paramaribo, Suriname

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Capillary blood

MeSH Terms

Conditions

Hepatitis B; Hepatitis C; Hepatitis D; HIV Infections

Interventions

Surveys and Questionnaires; Therapeutics

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Flaviviridae Infections; RNA Virus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Mathieu NACHER, MD, PhD

  Centre Hospitalier de Cayenne

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 12, 2021
• Study Start: January 1, 2018
• Primary Completion: February 8, 2019
• Study Completion: December 23, 2019
• Last Updated: June 7, 2023

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); SU (1)